PALM BEACH GARDENS, Fla., July 14, 2005 (PRIMEZONE) -- Pegasus Pharmaceuticals Inc. (Pink Sheets:PGUZ) today announced that its Cardiovisor 6C System performed extremely well during a recent blind pilot study which compared the Company's groundbreaking technology with standard electrocardiograph (ECG) machines.
The Cardiovisor 6C System is an advanced screening technology that provides physicians with a rapid 60 second solution for early, non-invasive screening of heart disease. This technology uses only six standard leads from wrists and ankles. (Only four electrodes make it possible to examine a fully clothed patient.) The device includes proprietary software that converts the electric conductivity of the cardiac tissue into a three-dimensional color coded visual portrait, which is simple for physicians to interpret. It allows testers to observe the condition of the heart muscle as well as the intensity of the heart stress load. The device provides a portrait of the patient's heart and an electrocardiogram, the mainstay in the screening of acute and chronic heart disease (CHD).
The Pegasus/Heartview ECV unit represents a new method of computer analysis for the screening of ischemic heart disease and other cardiac diseases with a highly sensitive analysis of the re-polarization phase, which is the most challenging phase of heart excitement in clinical interpretation. Data yielded by this new method on changes of just the re-polarization phase in various medical disorders have obvious differential screening features.
The pilot study was performed recently in a major New York hospital by heart specialists and physicians in an actual emergency room environment. The blind study compared the Pegasus/Heartview prototype, six-lead ElectroCardioVison (ECV) device to a twelve-lead traditional ECG unit on 109 patients.
The Pegasus/Heartview ECV showed substantially greater sensitivity than the traditional ECG with respect to ischemia and potentially superior screening capabilities. With respect to screening for heart abnormalities, the ECV almost matched the sensitivity of a 12-lead ECG that was read by an experienced cardiologist and was significantly superior on specificity. The ECV showed the potential for improving the speed and accuracy of screening for ischemic heart disease and other cardiac diseases that may not be identified using the traditional ECG unit. Despite the vast diagnostic value of the traditional ECG unit, having a faster, more portable automated device has the tremendous potential in cutting costs associated with ischemic heart disease.
Earlier clinical trials performed in Europe with the Pegasus/Heartview ECV device involved tests of 213 heart patients. The research was aimed at identifying the capacities of the ECV in the detection of heart disease and any changes in myocardium during treatment. The average sensitivity and specificity of the ECV were 79% and 76% respectively. The standard ECG unit was lower in sensitivity, ranging from 25 percent to 50 percent.
It is important to note that when all age groups are considered, ischemic heart disease (IHD) is the most common cause of death both in men and women. Postmortem studies on accident victims have shown that coronary arteriosclerosis often begins to develop prior to the age of 20 and is widespread even among adults who are asymptomatic. Sudden death may occur without advance warning and is a common presenting manifestation of IHD.
The blind study performed in New York produced similar results for the Pegasus/Heartview ECV device with a 72 percent result for sensitivity and a 66 percent result for specificity from a relatively small test group, but which featured a blind result read by cardiologists, which is in their terms "a very demanding real world test." Based on their findings in New York, the study stated, "The ECV device merits further testing for both identifying specific heart conditions and for screening populations."
The ECV unit demonstrated its potential for improving the speed and accuracy of diagnosing heart disease and other cardiac diseases that may not be identified using the traditional ECG unit. The portable, easy-to-use ECV device also demonstrated that its speed, portability, and its automated response has a tremendous potential in providing a non-invasive screening procedure for the early detection of heart disease and for cutting costs in the screening processes of patients. Earlier clinical trials in Europe and the pilot study recently completed in New York have proven the tremendous market potential of the Pegasus/Heartview Cardiovisor 6C System and its application to cardiologists, general practitioners, clinics, hospitals, the fitness industry, and emergency medical facilities. Further tests of the Pegasus/Heartview ECV device are now underway.
Pegasus Pharmaceuticals Inc., of Palm Beach Gardens, Florida recently acquired 51 percent interest in Heartview LLC Inc., based in Cleveland, Ohio, which holds the worldwide patent, manufacturing, and marketing rights of the innovative heart screening system, the Cardiovisor 6C System. An earlier version of this screening system has already been cleared for sale in Europe, and there is a patent pending for the Pegasus/Heartview ECV device in the United States.